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Seattle Genetics is reporting today on a batch of clinical trial results that represent a watershed moment for the company, its technology for creating “empowered antibodies” against cancer, and which could provide a new source of hope for patients with Hodgkin’s disease.

The company (NASDAQ: SGEN) and its partner, Cambridge, MA-based Millennium: The Takeda Oncology Company, are presenting detailed results today from a study of 102 patients who got brentuximab vedotin (SGN-35) as a treatment for relapsed forms of Hodgkin’s disease. Researchers found that one-third of the patients (34 percent) had their tumors completely eliminated after getting the new drug, while another 41 percent had their tumors shrink by half or more, and a total of 94 percent had at least some observable tumor shrinkage. All kinds of nitty gritty details on how long the remissions lasted, and the drug’s side effect profile, are being disclosed today at the American Society of Hematology (ASH) meeting in Orlando, FL.

Seattle Genetics plans to package this data in an application to the FDA by the end of March, in which it will seek clearance to start selling the product in the U.S., where it holds 100 percent of the commercial rights. Millennium, which has a lot of experience in blood cancers with its $1 billion hit bortezomib (Velcade), holds the rights to this drug in Europe and plans to seek regulatory clearance there in 2011. If the FDA allows the drug on the market next year, it will mean Seattle Genetics will be transformed from an R&D-only operation into a more diversified commercial organization. The drug is also being closely watched in the biotech industry, because it could be the first time anyone has been successful with an “empowered antibody”—a molecule that’s designed to zero in specifically on cancerous cells, carrying a potent tumor-killing toxin.

While about two-thirds of the 8,500 patients diagnosed in the U.S. with Hodgkin’s disease are successfully treated with chemotherapy, one-third eventually get relapsed, treatment-resistant forms that provide a grim prognosis—a life expectancy of just two to three years. The new Seattle Genetics drug could be the first treatment for this patient population in more than two decades. Seattle Genetics already released some of the results to investors in September, and its stock has soared 56 percent this year on the news, but this is the first time the data will get scrutinized in detail at a medical meeting with more than 20,000 people in attendance.

Clay Siegall

“I’ve been a part of many clinical trials before, and this is one of the best results I’ve ever seen,” says Robert Chen, a hematologist at the City of Hope in Duarte, CA, and an investigator on the study who will present to his peers at the ASH conference. “I’m very excited for patients with Hodgkin’s disease.”

Clay Siegall, the CEO who co-founded Seattle Genetics a dozen years ago, says he sees the new drug as a cornerstone in a plan for the company to become a much bigger force than it is today in cancer drug R&D. “We want to be the next Celgene, the next Genzyme, the next really important biotech company,” Siegall says. “We have the nucleus, and we have the technology to do it.”

Before going deep into the clinical trial results, a little science … Next Page »